Kornimate/medical-research-clean huggingface dataset:
investigation of non-inferiority of treatment of vulvovaginal dryness with wo2085 moisturising cream in comparison to a cream with 0.1% estriol

Conditions: Vulvovaginal Atrophy

Summary: the aim of the study is to gain further experience with regard to the performance of the medical device wo2085 moisturising cream in comparison to a cream with 0.1% estriol.

"vaginal dryness" is defined as dryness, itching, burning and pain unrelated to sexual intercourse.

Eligibility criteria:
inclusion criteria: * post-menopausal women with the subjective symptoms of "vulvovaginal dryness" with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 and a vas value "overall impairment of daily life due to the condition "vulvovaginal dryness" \> 0 on visit 1. * last menstruation more than 12 months before visit 1 or bilateral oophorectomy with or without hysterectomy more than 3 months before visit 1. * physical and mental healthy women as assessed by the medical history. * pap test performed within the last 12 months before visit 1 and result less than pap iii. * signed written informed consent before participation in the trial. * willingness to actively participate in the trial and to come to the scheduled visits. exclusion criteria: * known hypersensitivity against any of the ingredients of the test products. * any indication in the medical history regarding an impairment of the hepatic, renal, gastrointestinal, cardiovascular, pulmonary, endocrinological or hematological system (especially venous and arterial thromboembolism, ischemic stroke, myocardial infarction, porphyria) if clinically relevant for this clinical trial (cf. contraindications and warnings for estriol cream 0.1%). * known thrombophilic disorders (e.g. protein c, protein s or antithrombin deficiency). * breast cancer (acute and / or in the medical history or suspected). * estrogen-dependent tumor (acute and / or in the medical history or suspected, especially ovarian and / or endometrial carcinoma). * systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of serms (inter alia anti-estrogens) within 3 months before visit 1 and / or during the conduct of this trial. * intrauterine device (iud) with progestogen (mirena®, jaydess®) * pathological findings in cancer screening (papanicolaou iii, iii d - v in the cervical test) * pathological changes in the vaginal or cervix area, which are caused by estrogen deficiency (except symptoms and condition of "vulvovaginal dryness"), e.g. diminution of labia caused by estrogen deficiency, constricted introitus. * patients with known infectious diseases (e.g. hepatitis or hiv infection).

Keywords: vulvovaginal dryness
home-based exercises for patients with stroke

Conditions: Cerebrovascular Disorders; Brain Infarction; Brain Ischemia; Stroke

Summary: the aim of this study is the development and the implementation of a new protocol about home-based exercises, supported by an illustrated manual, for the treatment of individuals with stroke. the hypothesis is that this group of patients who are going to carry out the training of this study protocol are going to show improvement in measured parameters (functionality and physical performance), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.

1. program development: 27 exercises were selected, based on the most frequent motor alterations present in hemiparesis. three modes were created for each exercise: assisted active, active and resisted active executions. besides explanatory text, there were illustrative photos for all exercises and their modes. 2. program execution: all groups were submitted to a motor evaluation utilizing the fugl-meyer assessment (fma) and functional evaluation utilizing the functional independence measure (fim). after assessment, for the patients of the home-based exercise group (hbg) a group of home exercises was selected for each patient; these exercises were explained and performed one by one. the home-exercises were re-executed at each fortnightly visit, when any necessary correction was made. the next steps stipulated by the manual were taken, providing the patients with more complex exercises according to their progress. the patients in the supervised exercise training group (seg) participated in supervised individual exercise sessions two times per week. a physical therapist supervised these sessions. exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).the control group (cg) was assessed but reluctant or unable to regularly attend a supervised exercise program. the groups were reassessed after six months. 3. program assessment: the fugl-meyer assessment score and the functional independence measure score, measured at baseline and after six months, were compared between the groups.

Eligibility criteria:
inclusion criteria: * diagnosis of stroke, confirmed by clinical and radiological evidence * ability to understand and follow commands * willing and able to regularly attend a supervised exercise program exclusion criteria: * severe cognitive impairment * commodity that preclude them from undergoing training and assessment * neurological disease other than stroke

Keywords: stroke exercise and physical fitness
switching therapy from lamivudine to telbivudine versus continued lamivudine in adults with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (ldt) against continued lamivudine treatment. results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.


Eligibility criteria:
inclusion criteria: * documented clinical history compatible with chronic hepatitis b * patient has compensated liver disease * patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months other protocol-defined inclusion criteria may apply. exclusion criteria: * patient is pregnant or breastfeeding * patient is co-infected with hepatitis c, hepatitis d or hiv * patient previously received antiviral treatment for hepatitis b other than lamivudine in the preceding 12 months other protocol-defined exclusion criteria may apply.
postoperative prognosis management service based mhealth for prostate cancer patients

Conditions: Prostate Cancer

Summary: recently, the use of mobile health is increasing for the purpose of managing prognosis such as recurrence, survival and quality of life by using a wearable smart band and a smartphone application. in the era of the 4th revolution, mobile health for the purpose of comprehensive prognosis for cancer patients is becoming a very good tool. it is possible to confirm the clinical significance of short-term and temporary health care through a mobile application and a smart band during the treatment process for cancer patients, but the study is insufficient to generalize the number of subjects. therefore, for prostate cancer patients who need prognosis management after surgery, we will investigate the effect of a mobile application using a smart band which has a modular structure reflecting the treatment method and treatment process after surgery. this study targets patients who underwent prostate cancer surgery. an intervention group (app+iot device) uses a smart care application for 12 months. this application was tailored for prostate cancer patients and created by reflecting the treatment process after surgery. and they also uses a wearable smart band for 12 months. control group is provided general education through the hospital brochure. evaluation will be conducted 2-3days after surgery (before discharge), and at 1, 3, 6, and 12 months after surgery.


Eligibility criteria:
inclusion criteria: * patients 19 years of age or older who have been diagnosed with prostate cancer * patients who have completed surgical treatment for cancer within 3 months of screening and have no additional treatment planned * patients who can use a prognosis management application and can perform regular follow-up examinations in outpatient settings * patients carrying an android or ios smartphone * patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study exclusion criteria: * patients who have been treated within the last 3 months for other serious diseases (hematologic cancer, malignancy, etc.) * patients for whom additional treatment was planned due to cancer recurrence or metastasis * patients with severe cardiopulmonary disease who are unable to proceed with rehabilitation exercise programs * patients who find it difficult to proceed with the rehabilitation exercise program due to pain caused by bone metastasis and concerns about pathological fractures * patients who underwent lower extremity artificial joint tkra and thra * patients who are not eligible for rehabilitation exercise as judged by medical personnel
success of dailies total1 for astigmatism contact lenses in patients that have previously failed with toric contact lenses

Conditions: Astigmatism

Summary: the objective is to determine the percentages of past toric cl wearers (who dropped out of contact lens wear due to dissatisfaction with comfort or vision) who are satisfied with the comfort and vision of dt1fa contact lenses.

this is a single arm, prospective, non-comparative, open-label post market clinical study of satisfaction of past toric cl wearers, with dt1fa contact lenses. subjects will be assessed at a screening visit, and 2 follow-up visits. clinical evaluations will include measurement of visual acuity, manifest refraction, and administration a questionnaire

Eligibility criteria:
inclusion criteria: subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * gender: males and females. * subjects will be 18-39 years old. * history of previous unsuccessful astigmatism contact lens wearer with qualifying answer to screening questions: * i used to wear astigmatism correcting (toric) soft contact lenses. - (yes) * i stopped wearing my previous astigmatism correcting soft contact lenses because of one or more of the below reasons: * poor or fluctuating vision * discomfort * other * subjects must have 20/25 or better distance visual acuity in each eye with current best correction. * good general health (defined by prescription medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the pi). * ability to give informed consent. * willing and able to spend time for the study (subjects will be required to attend three study visits and wear contact lenses on days between study visits). exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * previous ocular surgery. * inability to be fit with the dt1fa lens design. * subjects that should be wearing a toric contact lens for best acuity but have chosen to continue in spherical contact lens wear. * history of accutane use. * ocular surface disease that in the investigator's opinion would interfere with contact lens wear. * history of comorbidities, including autoimmune disorders and diabetes. * irregular astigmatism as identified by pentacam. * history of amblyopia. * history of strabismus and/or history of eye muscle surgery. * history of monovision. * potential subjects who are pregnant. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
impact of adrenal incidentalomas and possible autonomous cortisol secretion on cardiovascular and metabolic alterations

Conditions: Adrenal Incidentaloma; Hypercortisolism; Adrenal Tumor

Summary: the investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible autonomous cortisol secretion (pacs). investigators hypothesize that adrenalectomy in selected patients, following the 2016 european congress of endocrinology (ece) guidelines, can improve metabolic parameters and cardiovascular risks and features.

adrenal incidentalomas are clinically silent masses discovered inadvertently during diagnostic imaging procedures performed for unrelated reasons. depending on the criteria applied, up to 50% of patients with adrenal incidentalomas may have biochemical evidence of cortisol excess. possible autonomous cortisol secretion (pacs), as defined in the 2016 european society of endocrinology guidelines, is characterized by a partial, incomplete suppression of the hypothalamic-pituitary-adrenal (hpa) axis without the typical signs of overt cortisol hypersecretion. investigators will perform a prospective longitudinal study in patients with adrenal incidentalomas associated with possible autonomous cortisol secretion, aiming to assess the effect of surgical and conservative management on cardiovascular and metabolic features. data will be detected at baseline, at 1 and at 5 years follow-up to quantitatively identify the different cardiovascular and metabolic alterations in: (1) patients with non-functioning adrenal adenoma; (2) patients with possible autonomous cortisol secretion receiving conservative management; (3) patients with possible autonomous cortisol secretion receiving adrenalectomy according to the 2016 european society of endocrinology guidelines; (4) patients without adrenal masses.

Eligibility criteria:
inclusion criteria: * incidentally detected adrenal mass exclusion criteria: * patients with overt cushing's syndrome, pheochromocytoma, conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage * patients taking medications influencing glucocorticoid production or metabolism * patients with psychiatric diseases or alcohol abuse * pregnancy
pharmacoeconomic analysis of first line meropenem versus standard antibiotic treatment in seriously infected secondary nosocomial sepsis syndrome patients.

Conditions: Sepsis

Summary: this study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an icu with secondary nosocomial sepsis, or who contract sepsis while resident in an icu.


Eligibility criteria:
inclusion criteria: * male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy. exclusion criteria: -

Keywords: antibiotic therapy sepsis treatment meropenem
sepsis in neutropenic patients: autologous stem cell transplantation as model: a transcriptomic approach

Conditions: Sepsis in Neutropenic Patients

Summary: treatment of cancer, and more particularly of haematological malignancies, partly relies on chemotherapy. most therapeutic regimens display various toxicities, one of the most common being haematological toxicity, affecting the three lineages. while anaemia and thrombopenia can be overcome by haematological growth factors and transfusion, one of the most severe life-threatening toxicity is sepsis that develops during neutropenia. neutropenia, despite the use of granulocyte colony-stimulating factors (g-csf) and antibiotics, is still a major limitation in chemotherapy which is responsible for the majority of treatment-related morbidity and mortality and for prolonged hospitalisation. in neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic patients. while the occurence of neutropenia and sepsis is often unpredictable and thus difficult to study in a prospective way, stem cell transplantation represents a quite convenient model to study such a question. autologous stem cell transplantation indications in haematology are mainly multiple myeloma and relapsed lymphoma or hodgkin disease. briefly, after a mobilization procedure, a graft of patient's hematopoietic stem cells is collected by cytapheresis and frozen. when the patient has reached complete remission by conventional chemotherapy, he benefits from a very high dose myeloablative chemotherapy (called "conditioning regimen"). the "conditioning regimen" targeted to have high antitumoral activity leads to a "cytokine storm" resulting in a "programmed inflammation". 36 hours after the lasting of the conditioning regimen, the cd34+ cells are thawed and infused to the patient. thus neutropenia usually begins at d4 post transplantation and lasts for 10 days, until graft becomes "functional". thus, the timing and duration of neutropenia are very homogeneous. during neutropenia, fever and sepsis are very frequent (\>80% patients), thus, most patient will be informative regarding sepsis, and there is an easy possibility of biological sampling before" programmed inflammation" (due to conditioning regimen), after inflammation before sepsis, then during and after the sepsis. since the patient is hospitalized, the kinetic monitoring is quite easy


Eligibility criteria:
inclusion criteria: * the criteria required to be candidate in an asch in our service(department) (age 18 - 66 years, myélome in 1 ° in reply partial line or lymphoma or complete answer after one 2 ° line, absence of preliminary visceral failure). informed, willing patients and having given their agreement in writing. exclusion criteria: * refusal of the patient
a cohort study to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of south asia

Conditions: Dengue

Summary: the purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of south asia.

this study aims to estimate the burden of dengue illness in selected sites south asia and to prepare sites for the conduct of future vaccine efficacy trials. operational goals include: * build long-term collaboration with sites in dengue-endemic regions of south asia where the incidence of clinical dengue illness can be studied. * establish dengue surveillance cohorts that can be followed long-term. * establish operational feasibility of future phase iii studies with regard to recruitment, case capture and sampling procedures. * prepare sites for participation in phase iii clinical endpoint studies.

Eligibility criteria:
inclusion criteria: * subject and/or subject's parent(s)/legally acceptable representative(s) (lar\[s\]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit\[s\] in case of afi, able to observe the signs of dengue and to understand how to take and report body temperature, etc.). * signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/lar(s) at the hospital/clinic or during a home visit. if the subject/subject's parent(s)/lar(s) are illiterate, the informed consent form (icf) (or informed assent form \[iaf\] when applicable) will be countersigned by an impartial witness. * subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child. * male or female aged between and including 6 months and 50 years at the time of enrolment. * subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period. exclusion criteria: * child in care. * participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement. * terminal illness based on investigator's judgement. * mental incapacity based on investigator's judgement.

Keywords: dengue non-laboratory confirmed dengue (non-lcd) acute febrile illness (afi) laboratory confirmed dengue (lcd)
cochlear implant speech in noise processing

Conditions: Hearing Loss, Adult-Onset; Speech Intelligibility; Hearing Loss, Extreme

Summary: the study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments.

despite the success of a cochlear implant (ci) for providing or improving hearing ability for people with severe hearing loss, everyday conversations in background noise are still the main clinical complaint. the goal of this study is to understand the neural mechanisms by which listeners with a ci detect speech in noisy environments, and to understand how these mechanisms differ across a variety of ci listeners, in order to determine what variables are most relevant for predicting successful outcome. therefore the purpose of pet neuroimaging in this study is to find the brain regions that relate to speech in noise effort using pet during auditory stimulation on a single session across a variety of ci users with different device configurations. an age-matched typical hearing control group provides a baseline for comparison. pet neuroimaging will be performed using a radioactive form of water, o-15 (an investigational agent), that will be injected into the body to examine brain blood flow using a pet/ct scanner.

Eligibility criteria:
cochlear implant subjects (enrollment is planned at n=120) - inclusion criteria: 1. between 18 and 99 years of age. 2. have a cochlear implant activated for more than one year. 3. eligible for research under the iowa cochlear implant project viii. 4. ability to understand and willingness to sign a written informed consent document. 5. severe hearing loss after age 16. normal hearing subjects (enrollment is planned at n=30) - inclusion criteria: 1. between 18 and 99 years of age. 2. have age typical hearing. 3. eligible for research under the iowa cochlear implant project viii. 4. ability to understand and willingness to sign a written informed consent document. exclusion criteria (all groups): 1. medical history includes seizure disorder, head injury, neurologic, metabolic, cardiovascular disease, or previous cerebrovascular event (unless approved by pi). 2. female self-reporting pregnancy. a urine pregnancy test will be performed prior to injection of the radiopharmaceutical. 3. currently taking medications which may affect cerebral blood flow (e.g., papaverine, ginkgo biloba, acetazolamide). 4. uncontrolled intercurrent illness that would limit compliance with study requirements per investigator.